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Enicepatide for weight management in people with overweight or obesity and type 2 diabetes

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Once-Weekly RO7795068 Administered to Participants With Obesity or Overweight and Type 2 Diabetes

Phase 3 Interventional Hoffmann-La Roche · NCT07351058

This trial tests whether enicepatide helps adults with overweight or obesity and type 2 diabetes lose weight compared with a placebo.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1600 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Locations36 sites (Guntersville, Alabama and 35 other locations)
Trial IDNCT07351058 on ClinicalTrials.gov

What this trial studies

This is a phase 3, randomized, placebo-controlled trial comparing multiple doses of enicepatide, a dual GLP-1/GIP receptor agonist, to placebo for weight management in people with overweight or obesity and type 2 diabetes. Participants must have a BMI ≥27 kg/m2 and HbA1c between 6.5% and 10%, and may be on stable oral diabetes therapy or diet/exercise alone but not on GLP-1 receptor agonists or DPP‑4 inhibitors. The drug is administered by injection and participants must be willing and able to self-administer or receive injections from a trained person. The study will collect efficacy outcomes for weight change and safety data across the enrolled dose groups at participating U.S. clinical sites.

Who should consider this trial

Good fit: Adults with type 2 diabetes (HbA1c 6.5–10%), BMI ≥27 kg/m2, who are on stable oral diabetes therapy or managed with diet/exercise and are willing to self-administer injections are the intended participants.

Not a fit: People with type 1 diabetes, a history of ketoacidosis or recent hyperosmolar coma, recent severe hypoglycemia, or current/recent use of GLP‑1 RAs or DPP‑4 inhibitors are excluded and are unlikely to benefit from joining this trial.

Why it matters

Potential benefit: If successful, enicepatide could produce meaningful weight loss and improved blood sugar control for people with type 2 diabetes and overweight or obesity.

How similar studies have performed: Other dual GLP‑1/GIP agonists such as tirzepatide have shown large weight loss and improved glycemic control in type 2 diabetes and obesity, but enicepatide is a newer agent with limited published phase 3 outcomes so far.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Ability and willingness to self-administer the study drug (or receive an injection from a trained individual if visually impaired or with physical limitations)
* Diagnosis of type 2 diabetes mellitus (T2DM) according to WHO classification or other locally applicable standards with HbA1c ≥6.5% to ≤10% determined by laboratory test at screening, and on stable oral therapy for at least 3 months prior to screening (if applicable). T2DM may be treated with diet/exercise alone or any oral anti-hyperglycemic medication (as per local labeling) EXCEPT dipeptidyl peptidase 4 (DPP-4) inhibitors or GLP-1 RA-based therapy.
* Body mass index (BMI) ≥27.0 kg/m\^2
* History of ≥1 self-reported unsuccessful diet/exercise effort to lose body weight

Exclusion Criteria:

* History of type 1 diabetes mellitus (T1DM) or any lifetime history of ketoacidosis or history of hyperosmolar state/coma within 12 months prior to screening
* Have had 1 or more episodes of severe hypoglycemia and/or has hypoglycemia unawareness within the 6 months prior to screening
* At least 2 confirmed fasting blood glucose values \>270 mg/dL (15.0 mmol/L) (on 2 non-consecutive days) during screening
* Self-reported change in body weight \>5 kg within 3 months prior to screening
* Obesity induced by other endocrinologic disorders (e.g., Cushing's syndrome) or diagnosed monogenetic or syndromic forms of obesity (e.g., melanocortin 4 receptor deficiency or Prader-Willi syndrome)
* Prior or planned surgical treatment for obesity. Liposuction or abdominoplasty if performed more than 1 year prior to screening is allowed.
* Known clinically significant gastric emptying abnormality (e.g., severe gastroparesis or gastric outlet obstruction)
* Poorly controlled hypertension at screening
* Have any of the following cardiovascular conditions within 3 months prior to screening: Acute myocardial infarction; Cerebrovascular accident (stroke)/transient ischemic attack; Unstable angina; Hospitalization due to congestive heart failure
* Treatment with any approved or investigational GLP-1-RA-based therapy (e.g., GLP-1 receptor mono agonist, GLP-1/GIP receptor dual agonist, GLP-1/GIP/Gluc receptor triple agonist) within 6 months prior to randomization

Where this trial is running

Guntersville, Alabama and 35 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Obesity or OverweightType 2 Diabetes Mellitus
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.